What medical screening is required for plasma donation to ensure donor and recipient safety?

Medical Screening for Plasma Donation

All plasma donations must undergo mandatory serological testing for syphilis, hepatitis B surface antigen (HBsAg), antibody to HIV, and antibody to hepatitis C virus (anti-HCV), with medical history screening for infectious disease risk factors to protect both donor and recipient safety. 1

Required Laboratory Testing

Mandatory Serological Screening

• Syphilis testing using a serologic test (e.g., rapid plasma reagin) is required for all plasma donations 1
• Hepatitis B surface antigen (HBsAg) testing is mandatory for all plasma donations to detect active HBV infection 1, 2
• Antibody to HIV (anti-HIV) testing via enzyme-linked immunoassay is required for all plasma donations 1, 2
• Antibody to hepatitis C virus (anti-HCV) testing is mandatory for all plasma donations 1, 2

Additional Recommended Testing

• Antibody to hepatitis B core antigen (anti-HBc) testing is recommended, as blood banks in the United States voluntarily began implementing this in 1986-1987 1
• Antibody to human T lymphotropic virus type I (anti-HTLV-I) testing is recommended for whole blood and plasma donations 1
• Alanine aminotransferase (ALT) testing was voluntarily adopted by US blood banks in 1986-1987 as a surrogate marker for hepatitis 1

Medical History Screening

Risk Factor Assessment

• Complete medical and social history focusing on risk factors for transmissible diseases, including sexual history, intravenous drug use, incarceration, and tattoos, is essential for all plasma donors 3, 4
• Donor Health Questionnaire (DHQ) must be completed to identify disqualifying conditions or behaviors that increase infectious disease transmission risk 5, 4
• Travel history is paramount for screening geographically restricted infections, including endemic fungal infections, flaviviruses, and parasitic diseases 2

Physical Examination

• Physical examination to identify signs of acute or chronic infection is recommended for all plasma donors 3
• Vital signs and general health assessment ensure donor safety during the plasmapheresis procedure 4

Timing and Window Period Considerations

Critical Testing Windows

• HIV window period is reduced to 5-10 days with nucleic acid testing (NAT), though antibody testing alone has a longer window 2, 3, 6
• HCV window period is 10-30 days with NAT, and 30-60 days for HBV with NAT 2
• All infectious disease testing must be current within 28 days of donation to ensure accuracy 3
• For donors with recent travel or high-risk exposures, waiting at least 2-4 weeks after return before testing allows adequate time for seroconversion 3

Donor Deferral Criteria

Absolute Contraindications

• HIV-positive status is an absolute contraindication for plasma donation intended for general use 2, 3, 6
• HBsAg-positive donors are generally contraindicated except for specific matched recipients 2, 3, 6
• HCV-positive donors are contraindicated for general plasma donation except when donating to HCV-positive recipients 2, 3, 6
• Active tuberculosis, meningoencephalitis from Cryptococcus or M. tuberculosis, rabies, lymphocytic choriomeningitis virus, and prion diseases are absolute contraindications 2

Acceptable with Precautions

• Syphilis-positive donors are acceptable with appropriate recipient treatment 2, 3
• CMV-positive and EBV-positive donors are not contraindicated but require tailored prophylaxis strategies for seronegative recipients 2, 3

Additional Safety Measures for Pooled Plasma Products

Viral Reduction Strategies

• Nucleic acid amplification testing (NAT) by polymerase chain reaction (PCR) is performed on mini-pools of plasma donations to detect viral genomes (HCV RNA plasma pool testing is mandatory in Europe) 7
• Solvent-detergent incubation and pasteurization (heat treatment in liquid phase) are the most commonly used viral inactivation treatments for pooled plasma products 7
• Nanofiltration (viral elimination by filtration) and specific dry-heat treatments serve as additional viral reduction steps 7

Common Pitfalls and Critical Considerations

• False-negative results during window periods remain a risk despite NAT, as no test can completely eliminate the window period 2, 6
• Low or undetectable antibody levels occur in 24.6-35.7% of individuals who report PCR-diagnosed infections, highlighting the importance of antibody titer verification 5
• Persistent positive PCR tests can occur in 62.9% of subjects 14-27 days after symptom resolution for certain infections, requiring extended deferral periods 5
• Hemodilution from transfusions or infusions may cause false-negative results; testing should ideally use pre-transfusion samples 6
• Selected donor populations for source plasma may contribute to excluding individuals at risk of carrying infectious agents, providing an additional safety layer 7